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Recruiting Not applicable

Orofacial Muscle Pressure and Maxillary Transverse Development

NCT07552441 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-05-01
Last updated
2026-04-27

Condition(s) studied

Maxillary Transversal Deficiency (Maxillary Constriction) and Perioral Muscle Pressures (Tongue, Lip, and Cheek)

Investigational drug(s) / intervention(s)

Orolingual Manometry using IOPI Pro Deluxe Kit

Orolingual Manometry using IOPI Pro Deluxe Kit: A standardized measurement of perioral muscle pressures (tongue, lip, and cheek) will be conducted using the Iowa Oral Performance Instrument (IOPI). The procedure involves placing a disposable, air-filled bulb at specific intraoral locations (e.g., retro-incisal for tongue pressure, buccal vestibule for cheek pressure). Participants are instructed to exert their maximum isometric force against the bulb for a specific duration. Each measurement is performed three times with 30-second rest intervals, and the peak pressure is recorded in kilopascals (kPa). This procedure is purely diagnostic and non-invasive, performed once for each participant before the initiation of any orthodontic intervention.

Study summary

Study Title: Investigation of the Effects of Tongue, Lip, and Cheek Pressures on the Development of Upper Jaw Narrowness

Introduction and Hypothesis The structure of our face and the alignment of our teeth are influenced not only by our genetics but also by the surrounding soft tissues, such as the lips, cheeks, and tongue. These muscles exert constant pressure on our teeth and jawbones. According to the "Equilibrium Theory," teeth stay in their proper positions when the inward pressure from the lips and cheeks is balanced by the outward pressure from the tongue.

The hypothesis of this study is that individuals with a narrow upper jaw (maxillary constriction) may have different muscle pressure patterns compared to those with normal jaw widths. We believe that identifying these pressure differences will help dentists and orthodontists better understand why jaw narrowness occurs and how to achieve more stable results after treatment.

What is Being Measured? To measure these delicate pressures, we use a specialized, high-tech device called the Iowa Oral Performance Instrument (IOPI). This device uses a small, air-filled balloon (bulb) that the patient presses with their tongue or lips. It allows us to measure muscle strength and endurance in "kilopascals" (a unit of pressure) without any pain or discomfort.

Study Procedure

This study will involve patients aged 12 to 25 who are seeking orthodontic treatment at Van Yüzüncü Yıl University. We will divide the participants into two groups:

Patients with a narrow upper jaw.

Patients with a normal upper jaw width (the control group).

Before any orthodontic braces are applied, we will measure:

Tongue Pressure: How hard the tongue can push against the roof of the mouth.

Lip Pressure: The strength of the upper and lower lips.

Cheek (Buccal) Pressure: The pressure exerted by the cheeks during rest and function.

Importance of the Study While many studies have looked at how these muscles affect the forward or backward position of teeth, there is very little research on how they affect the width of the jaw. By comparing these two groups, we hope to discover whether "weak" or "overactive" muscles contribute to a narrow palate. This information could lead to new treatment methods that focus not just on moving teeth, but also on training the oral muscles to ensure that the beautiful smiles created by orthodontists last a lifetime.

Eligibility

Sex
ALL
Min age
12 Years
Max age
25 Years
Healthy volunteers
Accepted
Inclusion Criteria:Participants aged between 12 and 25 years.Diagnosed as Skeletal Class I (ANB angle: $0\^\\circ$ to $4\^\\circ$).Experimental Group: Clinical and radiographic diagnosis of maxillary transversal constriction.Control Group: Normal maxillary transversal width with no crossbite or constriction.Permanent dentition (excluding third molars).Good oral hygiene and no active periodontal disease.Ability to understand and follow instructions for the IOPI measurement protocol. \- Exclusion Criteria:Previous orthodontic or orthognathic surgical treatment. History of craniofacial anomalies or syndromes (e.g., cleft lip and palate). Neuromuscular disorders or systemic diseases affecting muscle function. History of trauma to the jaw or facial region. Congenitally missing teeth (hypodontia) or extensive prosthetic restorations. Macroglossia or severe tongue-tie (ankyloglossia). Use of medications that may influence muscle tone (e.g., muscle relaxants). Presence of large tonsils or adenoids that significantly obstruct the airway. \-

Primary outcome measure(s)

  • Maximum Voluntary Tongue Pressure — Baseline (A single measurement taken prior to the initiation of any orthodontic treatment).
    The maximum isometric pressure exerted by the tongue against the hard palate, measured in kilopascals (kPa) using the Iowa Oral Performance Instrument (IOPI). This value represents the peak functional strength of the tongue.

Trial sites (1)

FacilityCityRegionStatus
Van Yüzüncü Yıl University, Faculty of Dentistry, Department of Orthodontics Van Van Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07552441 on ClinicalTrials.gov ↗ ← All trials in Turkey